• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
Device acute kidney injury test system
Definition An acute kidney injury test system is intended to measure one or more analytes in human samples as an aid in the assessment of a patient's risk for developing acute kidney injury.Test results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including conifmration by alternative methods.
Physical State The test system may include clinical analyzers, reagents, calibrators, and controls.
Technical Method Assay to measure analyte(s) that are markers of Acute Kidney Injury
Target Area The test system is an in vitro diagnostic device that measures human samples.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodePIG
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.1220
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
-
-